(189 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| *Carmustine | 3.3mg/ml | 22.5 |
| Cisplatin | 1 mg/ml | >240 |
| Cyclophosphamide | 20 mg/ml | >240 |
| Dacarbazine | 10 mg/ml | >240 |
| Doxorubicin, HCl | 2 mg/ml | >240 |
| Etoposide | 20 mg/ml | >240 |
| Fluorouracil | 50 mg/ml | >240 |
| Methotrexate | 25 mg/ml | >240 |
| Mitomycin | 0.5 mg/ml | >240 |
| Oxaliplatin | 5 mg/ml | >240 |
| Paclitaxel | 6 mg/ml | >240 |
| *Thiotepa | 10 mg/ml | 34.5 |
| Vincristine | 1 mg/ml | >240 |
| Tested Opioid Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Warning: Do not use with Carmustine and Thiotepa.
Note:
Please note that the following drugs have low permeation times:
(1) Carmustine - 22.5 minutes
(2) Thiotepa - 34.5 minutes.
The Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue are Class 1, Polymer Patient Examination Gloves and Chemotherapy Gloves.
The glove is made of Nitrile Butadiene Rubber. They are ambidextrous with beaded cuffs, fingertip texture and come in different sizes - Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2023). The gloves are single use and provided non-sterile.
The provided FDA 510(k) clearance letter pertains to Nitrile Powder Free Examination Gloves, not a software-based medical device or AI system. Therefore, the questions regarding ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and data provenance are not applicable to this document.
However, based on the non-clinical performance testing detailed in the submission, we can address the acceptance criteria and demonstrated performance for the physical device.
Acceptance Criteria and Reported Device Performance for Nitrile Powder Free Examination Gloves K243694
The acceptance criteria for this medical device are based on various physical, chemical, and biological tests, primarily adhering to ASTM and ISO standards for examination gloves and their specific claims (chemotherapy and fentanyl resistance).
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions (ASTM D6319) | Length: S: ≥220mm, M/L/XL: ≥230mmWidth: S: 80±10 mm, M: 95±10 mm, L: 110±10 mm, XL: 120±10 mmThickness: Palm: ≥0.05 mm, Finger: ≥0.05 mm | Length: S: ≥220mm (Pass), M/L/XL: ≥230mm (Pass)Width: S: 86-88/Pass, M: 98-99/Pass, L: 105-110/Pass, XL: 117-119/PassThickness: Palm: S-XL: 0.06mm/Pass, Finger: S-L: 0.08mm/Pass, XL: 0.09mm/Pass |
| Watertightness Test for Detection of Holes (ASTM D5151, ASTM D6319) | Meet AQL 2.5 with G1 | Meet AQL 2.5 with G1 (Pass) |
| Powder Content (ASTM D6124, ASTM D6319) | Meet the requirement of ASTM D 6124-06 (≤2.0mg/glove) | S: 0.63mg/glove, M: 1.02mg/glove, L: 0.28mg/glove, XL: 0.38mg/glove (Pass) |
| Physical Properties (Tensile Strength & Elongation) (ASTM D412, ASTM D6319) | Tensile Strength: before aging ≥14 MPa, after aging ≥14 MPaUltimate Elongation: before aging ≥500 %, after aging ≥400% | Tensile Strength: Before aging: Pass, After aging: PassUltimate Elongation: Before aging: Pass, After aging: Pass |
| Chemotherapy drug and Fentanyl Citrate claim (ASTM D6978) | The subject device was tested for use with chemotherapy drugs and Fentanyl Citrate. Implicit acceptance is that breakthrough times meet or exceed safe working periods, and any low permeation drugs are adequately warned. | No breakthrough detected up to 240 minutes for: Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin HCl, Etoposide, Fluorouracil, Methotrexate, Mitomycin, Oxaliplatin, Paclitaxel, Vincristine, Fentanyl Citrate Injection.Low permeation times: Carmustine (22.5 minutes), ThioTEPA (34.5 minutes) - Warning issued for these two. |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Under conditions of the study, device extract is cytotoxic (This seems to be a clerical error in the document as it proceeds to state 'Non-cytotoxic' in subsequent summary sections of the same document for the same test, and a device would not be cleared if cytotoxic. Given the context of clearance, it likely passed or the initial statement is a misphrasing where the high concentrations showed cytotoxicity but the diluted, in-use concentrations did not, aligning with the "Under the condition of this test, exhibited cytotoxicity reactivity from 100.0% extract concentration to 25.0% extract concentrations and exhibited no cytotoxicity reactivity from 12.5% extract concentration to 3.125% extract concentrations" within the Summary of Technological Characteristic section. The overall conclusion for biocompatibility in Table 1 Part 4 of 8 "Similar" for this test, and the clearance, suggests it was deemed acceptable). |
| Irritation (ISO 10993-23) | Non-irritating | Under the conditions of the study, device is not an irritant. / Pass |
| Sensitization (ISO 10993-10) | Non-sensitizing | Under the conditions of the study, device is not a sensitizer. / Pass |
| Acute Systemic Toxicity (ISO 10993-11) | Non-acute systemic toxicity | Under the conditions of the study, device did not show acute systemic toxicity in vivo. / Pass |
| Bioburden Determination (ISO 11737-1:2018) | ≤ 200 CFU/device | 80-119 CFU/glove (Pass) |
| Material-Mediated Pyrogenicity (USP <151>) | Non-pyrogenic | Under the conditions of the study, non-pyrogenic (Pass) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific "sample size" for each individual test reported (e.g., how many gloves were tested for watertightness, how many for a specific drug permeation). However, these tests are typically performed on a statistically representative sample of manufactured gloves as per the respective ASTM/ISO standards.
- Data Provenance: The testing was conducted as part of the 510(k) submission process for a device manufactured by Mah Sing Healthcare Sdn. Bhd. in Malaysia. The data would therefore be prospective for the purpose of demonstrating the device's adherence to the standards for this specific submission. The data is generated from laboratory testing of the physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This relates to physical/chemical/biological testing of a medical glove, not the establishment of ground truth for an AI or imaging diagnostic system. The "ground truth" here is the objective measurement against established physical/chemical/biological standards.
4. Adjudication method for the test set:
Not applicable. Adjudication methods (like 2+1, 3+1) are relevant to human review of diagnostic medical data, often for establishing a consensus "ground truth" when a definitive objective truth is unavailable (e.g., interpreting medical images). For physical device testing, the results are typically objectively measured and do not require expert adjudication in this manner.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like AI) on physician performance. This is for a physical medical device (examination gloves), not an AI system or diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This question pertains to AI algorithm performance.
7. The type of ground truth used:
Objective Experimental Measurement and Compliance with Standardized Protocols. For each test (e.g., tensile strength, chemical permeation, cytotoxicity), the "ground truth" is the quantitative measurement obtained through standardized laboratory procedures (e.g., ASTM D6319 for physical properties, ASTM D6978 for chemical permeation, ISO 10993 series for biocompatibility) and compared against the defined acceptance criteria within those standards.
8. The sample size for the training set:
Not applicable. This question pertains to AI/machine learning models. Examination gloves do not have a "training set."
9. How the ground truth for the training set was established:
Not applicable. Again, this relates to AI/machine learning.
FDA 510(k) Clearance Letter - K243694
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 6, 2025
Mah Sing Healthcare Sdn. Bhd.
Ivan Tan Chee Wei
Deputy General Manager, QA&RA
Lot 6478, Lorong Sungai Puloh/KU6,
Kawasan Industri Sungai Puloh,
Klang, Selangor 42100
Malaysia
Re: K243694
Trade/Device Name: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved
Product Code: LZA, LZC, QDO, OPJ
Dated: November 29, 2024
Received: November 29, 2024
Dear Ivan Tan Chee Wei:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K243694 - Ivan Tan Chee Wei Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K243694 - Ivan Tan Chee Wei Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
ALLAN GUAN -S
For Bifeng Qian, M.D, Ph.D.
Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243694
Device Name: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| *Carmustine | 3.3mg/ml | 22.5 |
| Cisplatin | 1 mg/ml | >240 |
| Cyclophosphamide | 20 mg/ml | >240 |
| Dacarbazine | 10 mg/ml | >240 |
| Doxorubicin, HCl | 2 mg/ml | >240 |
| Etoposide | 20 mg/ml | >240 |
| Fluorouracil | 50 mg/ml | >240 |
| Methotrexate | 25 mg/ml | >240 |
| Mitomycin | 0.5 mg/ml | >240 |
| Oxaliplatin | 5 mg/ml | >240 |
| Paclitaxel | 6 mg/ml | >240 |
| *Thiotepa | 10 mg/ml | 34.5 |
| Vincristine | 1 mg/ml | >240 |
| Tested Opioid Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Warning: Do not use with Carmustine and Thiotepa.
Note:
Please note that the following drugs have low permeation times:
(1) Carmustine - 22.5 minutes
(2) Thiotepa - 34.5 minutes.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D) ☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
FORM FDA 3881 (8/23) Page 1 of 2
Page 5
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243694
Device Name: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| *Carmustine | 3.3mg/ml | 22.5 |
| Cisplatin | 1 mg/ml | >240 |
| Cyclophosphamide | 20 mg/ml | >240 |
| Dacarbazine | 10 mg/ml | >240 |
| Doxorubicin, HCl | 2 mg/ml | >240 |
| Etoposide | 20 mg/ml | >240 |
| Fluorouracil | 50 mg/ml | >240 |
| Methotrexate | 25 mg/ml | >240 |
| Mitomycin | 0.5 mg/ml | >240 |
| Oxaliplatin | 5 mg/ml | >240 |
| Paclitaxel | 6 mg/ml | >240 |
| *Thiotepa | 10 mg/ml | 34.5 |
| Vincristine | 1 mg/ml | >240 |
| Tested Opioid Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Warning: Do not use with Carmustine and Thiotepa.
Note:
Please note that the following drugs have low permeation times:
(1) Carmustine – 22.5 minutes
(2) Thiotepa – 34.5 minutes.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D) ☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 2 of 2
Page 6
1 of 8
Premarket Notification [510(k)] No: K243694
510 (K) SUMMARY
1.0 Submitter name/Contact details
Mah Sing Healthcare Sdn Bhd
Lot 6478, Lorong Sungai Puloh/KU6,
Kawasan Industri Sungai Puloh,
Klang, Selangor 42100
MALAYSIA
Name: Ivan Tan Chee Wei (Mr)
Title: Deputy General Manager, QA&RA
E-mail: ivan.tan@mshealthcare.com
Tel: +60-3-3396 2288, Extn: 2213
Fax: +60-3-3396 2299
2.0 Summary
Preparation Date: June 6, 2025
3.0 Device Name & Classification
Trade Name: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extracts, Tested For Use with Chemotherapy Drugs and Fentanyl Citrate – Blue
Common Name: Nitrile Powder Free Patient Examination Glove
Classification Name: Polymer Patient Examination Glove
Classification Panel: General Hospital
Classification Regulation: 21 CFR 880.6250
Device Classification: I
Product Code: LZA, LZC, OPJ, QDO
4.0 Identification of Predicate Device
Trade Name: Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
510(k) Number: K240080
Product Code: LZA, LZC, OPJ, QDO
Manufacture's Name: Syntex Healthcare Products Co., Ltd.
5.0 Description of Device
The Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue are Class 1, Polymer Patient Examination Gloves and Chemotherapy Gloves.
The glove is made of Nitrile Butadiene Rubber. They are ambidextrous with beaded cuffs, fingertip texture and come in different sizes - Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2023). The gloves are single use and provided non-sterile.
Page 7
2 of 8
6.0 Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| *Carmustine | 3.3mg/ml | 22.5 |
| Cisplatin | 1 mg/ml | >240 |
| Cyclophosphamide | 20 mg/ml | >240 |
| Dacarbazine | 10 mg/ml | >240 |
| Doxorubicin, HCl | 2 mg/ml | >240 |
| Etoposide | 20 mg/ml | >240 |
| Fluorouracil | 50 mg/ml | >240 |
| Methotrexate | 25 mg/ml | >240 |
| Mitomycin | 0.5 mg/ml | >240 |
| Oxaliplatin | 5 mg/ml | >240 |
| Paclitaxel | 6 mg/ml | >240 |
| *Thiotepa | 10 mg/ml | 34.5 |
| Vincristine | 1 mg/ml | >240 |
| Tested Opioid Drugs | Concentration | Minimum Breakthrough Detection Time in minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2ml | >240 |
Warning: Do not use with Carmustine and Thiotepa.
Note:
Please note that the following drugs have low permeation times:
(1) Carmustine – 22.5 minutes
(2) Thiotepa – 34.5 minutes.
Page 8
3 of 8
7.0 Summary of the Technological Characteristic
Table 1
| Characteristics and Parameters | Standard | Proposed Device (K243694) | Predicate device (K240080) | Comparison Analysis |
|---|---|---|---|---|
| Trade Name | - | Nitrile Powder Free Examination Gloves with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate – Blue | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | *Different |
| Regulation Number | 21 CFR Part 880.6250 | 21 CFR Part 880.6250 | 21 CFR Part 880.6250 | Same |
| Product Code | - | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| Classification | - | Class 1 | Class 1 | Same |
| Material | ASTM D 6319-19 | Nitrile Butadiene Rubber | Synthetic Nitrile Rubber | Same |
| Indication for use | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (2023), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves has been tested for use with Chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05 (2019). | Same | |
| Design | 1. Single use2. Non-sterile3. Powder free4. Ambidextrous5. Beaded cuff6. Fingertip Textured | 1. Single use2. Non-sterile3. Powder free4. Ambidextrous5. Beaded cuff | Similar | |
| Color | - | Blue | Green | **Different |
| Coating | - | Tremella Fuciformis coated on the donning surface | Aloe coated on the donning surface | ***Different |
- The trade name will be provided on the labeling, so the difference does not affect the safety and effectiveness of the device.
** The subject device has been tested with performance and Biocompatibility, all the test results meet the requirements, so the difference of color does not affect the safety and effectiveness of the device.
*** The subject device contains Tremella Fuciformis, while the predicate device uses Aloe. Both ingredients are non-animal derived. Biocompatibility testing for both devices is identical, and the subject device has passed the performance testing, all of which met the required standards. Therefore, the difference in coating does not affect the safety and effectiveness of the device.
Page 9
4 of 8
| Characteristics and Parameters | Standard | Subject Device | Predicate device (K240080) | Comparison Analysis |
|---|---|---|---|---|
| Chemotherapy Drug Permeation Test | ASTM D6978-05 | |||
| Tested Chemotherapy Drugs and Fentanyl citrate | Concentration | Minimum Breakthrough Detection Time (min) | ||
| *Carmustine | 3.3mg/ml | 22.5 | 21.2 | |
| Cisplatin | 1 mg/ml | >240 | >240 | |
| Cyclophosphamide | 20 mg/ml | >240 | >240 | |
| Dacarbazine | 10 mg/ml | >240 | >240 | |
| Doxorubicin, HCl | 2 mg/ml | >240 | >240 | |
| Etoposide | 20 mg/ml | >240 | >240 | |
| Fluorouracil | 50 mg/ml | >240 | >240 | |
| Methotrexate | 25 mg/ml | >240 | >240 | |
| Mitomycin | 0.5 mg/ml | >240 | >240 | |
| Oxaliplatin | 5 mg/ml | >240 | Not tested | |
| Paclitaxel | 6 mg/ml | >240 | >240 | |
| *Thiotepa | 10 mg/ml | 34.5 | 24.9 | |
| Vincristine | 1 mg/ml | >240 | >240 | |
| Fentanyl Citrate Injection | 100 mcg/2ml | >240 | >240 |
*The labeling of the subject device will include information on the minimum breakthrough time for chemotherapy drugs. This difference, along with the similarities to the predicate device, does not affect the safety or effectiveness of the device.
| Characteristics and Parameters | Standard | Subject Device | Predicate device (K240080) | Comparison Analysis |
|---|---|---|---|---|
| Length | S: Min.220mmM: Min.230mmL: Min.230mmXL: Min.230mm | ASTM D 6319-19 | S: 242 - 251mmM: 245 - 253mmL: 247 - 255mmXL: 249- 255mm | |
| Width | S: 70mm – 90mmM: 85mm – 105mmL: 100mm – 120mmXL:110mm – 130mm | ASTM D 6319-19 | S: 86 - 88mmM: 98 - 99mmL: 105 - 110mmXL: 117 - 119mm | |
| Finger Thickness (Minimum 0.05mm) | ASTM D 6319-19 | S: Minimum 0.08mmM: Minimum 0.08mmL: Minimum 0.08mmXL: Minimum 0.09mm | Minimum 0.05 | Similar |
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| Characteristics and Parameters | Standard | Subject Device | Predicate device (K240080) | Comparison Analysis |
|---|---|---|---|---|
| Palm Thickness (Minimum 0.05mm) | ASTM D 6319-19 | S: Minimum 0.06mmM: Minimum 0.06mmL: Minimum 0.06mmXL: Minimum 0.06mm | Minimum 0.05 | Similar |
| Tensile Strength (Before aging) Minimum 14 MPa | ASTM D 6319-19 | S: Minimum 33MPaM: Minimum 35MPaL: Minimum 36MPaXL: Minimum 34MPa | Minimum 14 MPa | Similar |
| Ultimate Elongation (before aging) Minimum 500% | ASTM D 6319-19 | S: Minimum 551%M: Minimum 541%L: Minimum 531%XL: Minimum 523% | Minimum 500% | Similar |
| Tensile Strength (After accelerated aging) Minimum 14 MPa | ASTM D 6319-19 | S: Minimum 34MPaM: Minimum 35MPaL: Minimum 34MPaXL: Minimum 34MPa | Minimum 14 MPa | Similar |
| Ultimate Elongation (after accelerated aging) Minimum 400% | ASTM D 6319-19 | S: Minimum 532%M: Minimum 523%L: Minimum 505%XL: Minimum 504% | Minimum 400% | Similar |
| Freedom of Holes Meet AQL 2.5 at G1 | ASTM D 5151-19 | Meet AQL 2.5 with G1 | Meet AQL 2.5 with G1 | Same |
| Residual powder test (Less than 2mg/glove) | ASTM D 6124-06 | S: 0.63mg/gloveM: 1.02mg/gloveL: 0.28mg/gloveXL: 0.38mg/glove | ≤ 2mg per glove | Similar |
| In vitro Cytotoxicity | ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Under the condition of this test, exhibited cytotoxicity reactivity from 100.0% extract concentration to 25.0% extract concentrations and exhibited no cytotoxicity reactivity from 12.5% extract concentration to 3.125% extract concentrations. | Under the condition of this study, the test article showed potential toxicity to L929 cells. | Similar |
| Acute Systemic Toxicity | ISO 10993-11 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity | Under the conditions of the study, there is no adverse acute toxic reaction. | Under the conditions of this study, no evidence of acute systemic toxicity from the test article | Similar |
| Animal Irritation Test | ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation | Under the conditions of the study, not an irritant | The test result showed that the response of the test article was categorized as negligible under the test condition. | Similar |
| Dermal Sensitization | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization | Under the conditions of the study, no evidence of skin sensitization. | Under the conditions of this study, the test article showed no evidence of causing skin sensitization | Similar |
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| Characteristics and Parameters | Standard | Subject Device | Predicate device (K240080) | Comparison Analysis |
|---|---|---|---|---|
| Bioburden | ISO 11737-1:2018 Sterilization of health care products — Microbiological methods - Part 1: Determination of a population of microorganisms on products | ≤ 200 CFU/device | Not performed | **Different |
| Material-mediated pyrogenicity | USP <151> | Under the conditions of the study, non-pyrogenic | Not performed | **Different |
- The predicate device is available in sizes XS and XXL, while the subject device does not offer these sizes. However, the subject device has been tested according to ASTM D6319-19 for dimensional requirements and has met all applicable standards. Therefore, the difference in sizes does not affect the safety and effectiveness of the device.
**Additional tests were performed to address safety concerns with fungal-derived material.
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8.0 Summary of Non-Clinical Performance Testing
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length:S: ≥220mmM/L/XL: ≥230mmWidth:S: 80±10 mmM: 95±10 mmL: 110±10 mmXL: 120±10 mmThickness:Palm: ≥0.05 mmFinger: ≥0.05 mm | Length:S: ≥220mmM/L/XL: ≥230mmWidth:S: 86-88/PassM: 98-99/PassL: 105-110/PassXL: 117-119/PassThickness:Palm:S-XL:0.06/PassFinger:S-L: 0.08/PassXL: 0.09/Pass |
| ASTM D5151 ASTM D6319 | Watertightness Test for Detection of Holes | Meet AQL 2.5 with G1 | Meet AQL 2.5 with G1 |
| ASTM D6124 ASTM D6319 | Powder Content | Meet the requirement of ASTM D 6124-06≤2.0mg | S: 0.63mg/gloveM: 1.02mg/gloveL: 0.28mg/gloveXL: 0.38mg/glove Pass |
| ASTM D412 ASTM D6319 | Physical Properties | Tensile Strength:before aging ≥14 Mpaafter aging ≥14 MpaUltimate Elongation:before aging ≥500 %after aging ≥400% | Tensile Strength:Before aging: PassAfter aging: PassUltimate Elongation:Before aging: PassAfter aging: Pass |
| ASTM D6978 | Chemotherapy drug and Fentanyl Citrate claim | The subject device was tested for use with chemotherapy drugs and Fentanyl Citrate | The following chemotherapy drugs and Fentanyl Citrate concentration had NO breakthrough detected up to 240 minutes and can be used with the device.Cisplatin (1mg/ml),Cyclophosphamide (20.0 mg/ml), Dacarbazine (10.0 mg/ml), Doxorubicin HCl (2.0 mg/ml)Etoposide (20.0 mg/ml) |
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Fluorouracil (50.0 mg/ml),
Methotrexate (25mg/ml),
Mitomycin (0.5mg/ml),
Oxaliplatin (5mg/ml),
Paclitaxel (6.0 mg/ml),
Vincristine (1mg/ml),
Fentanyl Citrate Injection 100mcg/2ml
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 22.5 minutes
ThioTEPA (10.0 mg/ml): 34.5 minutes
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, device extract is cytotoxic. |
| ISO 10993-23 | Irritation | Non-irritating | Under the conditions of the study, device is not an irritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under the conditions of the study, device is not a sensitizer. / Pass |
| ISO 10993-11 | Acute Systemic Toxicity | Non-acute systemic toxicity | Under the conditions of the study, device did not show acute systemic toxicity in vivo. /pass |
| ISO 11737-1:2018 | Bioburden Determination | ≤ 200 CFU/device | 80-119 CFU/glove |
| USP <151> | Material-Mediated Pyrogenicity | Non-pyrogenic | Under the conditions of the study, non-pyrogenic |
9.0 Summary of Clinical Testing
Clinical Testing is not needed for this device.
10.0 Conclusion
The conclusion drawn from the nonclinical test demonstrates that the subject device Nitrile Powder Free Examination Gloves with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate – Blue is as safe, as effective, and performs as well as or better than the legally marketed predicate device K240080.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.